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Precision for Medicine is a Clinical Research Organization specializing in precision medicine, combining novel clinical trial designs, operational expertise, medical leadership, biomarker analytics, and a focus on rare diseases and oncology.
The Project Support Specialist will serve as a cross-functional team member providing administrative and operational support to clinical trial projects. This role is fully remote and can be based in Poland, Serbia, Slovakia, Hungary, or Romania.
Key Responsibilities:
- Create and maintain project timelines in MS Project or similar systems, ensuring updates are documented and distributed to study team members
- Schedule internal and external meetings; prepare and circulate agendas; take and file meeting minutes in the Trial Master File
- Perform Clinical Trial Management System (CTMS) activities including maintaining study milestone dates, updating contact lists, managing enrollment projections, and submitting/tracking helpdesk tickets
- Prepare, assign, and document study-specific training; manage training records and identify training gaps
- Establish and maintain study-level SharePoint sites and shared working spaces with appropriate access controls
- Create and manage project-specific email boxes and distribution lists
- Manage user access to study systems by submitting requests and conducting periodic access reviews
- Order study supplies and manage supply-related inquiries
- Order, collect, collate, and prepare study binders for distribution
- Maintain various study trackers as directed by project leadership
- Send communications to study sites, investigators, and stakeholders (SUSARs, newsletters, updates)
- Support distribution and tracking of IND Safety Reports/SUSARS/CIOMS as applicable
- Support translation of site-level documents per local and regional standards
- Act as point of contact for project-related requests from team members, sponsors, and vendors
- Support preparation, distribution, and reconciliation of study materials (Operations Manual, ISF, patient cards)
- Support production of study reports and updates (site initiation, activation, recruitment)
- Perform additional duties as assigned by project leadership
Requirements:
- 4-year college degree or equivalent experience in business, scientific, or healthcare discipline
- Minimum 2 years of relevant experience as a Clinical Trial Assistant, Clinical Support Specialist, or similar position
- Fluency in Microsoft Office (Outlook, Word, Excel, PowerPoint)
- Customer service orientation with flexibility, teamwork, and strong attention to detail
- Professional-level English proficiency (verbal and written)
- Working knowledge of ICH-GCP, company SOPs, and regulatory guidance
- Solid interpersonal skills
- Strong self-motivation, detail-oriented, able to work independently and in team environments
- Strong written and verbal communication skills
- Commitment to professional standards
